Urinary incontinence treatment with wireless energy supply

ABSTRACT

A urinary incontinence treatment apparatus comprises an operable restriction device ( 4 ) to be implanted in a patient for engaging the urethra ( 66 ) or urine bladder, to form a restricted urine passageway in the urethra or urine bladder. The restriction device is operable to change the restriction of the urine passageway. An energy transmission device ( 10 ) is provided for wireless transmission of energy from outside the patient&#39;s body to inside the patient&#39;s body for use in connection with the operation of the restriction device including enlarging or restricting the urine passageway.

[0001] The present invention relates to a urinary incontinence treatmentapparatus comprising an operable restriction device implantable in apatient, who suffers from urinary incontinence, for engaging the urethraor urine bladder, to form a restricted urine passageway in the urethraor urine bladder. The restriction device is operable to change therestriction of the urine passageway, i.e. to close and enlarge the urinepassageway. The term “patient” includes an animal or a human being.

[0002] Urine incontinence is a widespread problem. Many people arehelped through training of the muscles in the pelvic floor but too manyhave severe problems with urine leakage. Many different solutions tothis problem have been tried. For example, there is a prior manuallyoperated urine incontinence treatment apparatus having an artificialhydraulic sphincter device engaging the urethra and connected to anelastic reservoir implanted in the scrotum or in the region of the labiamajor. A disadvantage of this prior apparatus is that over time hardfibrosis is developed around the reservoir, which may cause malfunctionof pumping components. Furthermore, it is a rather complicated task tomanually squeeze the elastic implanted reservoir to pump hydraulic fluidto open the sphincter device when the patient needs to urinate. Inparticular women can get their fingers wet. The created fibrosis willsooner or later become a hard fibroid layer, which may make it even moredifficult to pump the reservoir. Yet a further disadvantage is that theuse of hydraulic fluid always entails a risk of fluid leaking fromimplanted hydraulic components.

[0003] A prior hydraulic apparatus designed to compress the urethra isdisclosed in U.S. Pat. No. 5,520,606. A prosthetic sphincter with aninflatable cuff, which surrounds the urethra or encloses it on twosides, is disclosed in for example U.S. Pat. Nos. 4,571,749 and4,222,377. U.S. Pat. No. 4,969,474 discloses a hydraulic method fortreating both men and women with urinary incontinence problems in thesame way. The apparatus of U.S. Pat. No. 4,969,474 includes a reservoircontaining fluid and an inflatable compression means designed tocompress urethra without risking tissue loss or necrosis to occur. Anartificial hydraulically operated urethra sphincter employing anexternal magnet to achieve closure of the urethra cuff is disclosed inU.S. Pat. No. 5,562,598.

[0004] A prior mechanical prosthetic sphincter disclosed in U.S. Pat.No. 4,619,245 comprises a manually controllable actuating component forimplanting at a convenient location in the patient's body.

[0005] The object of the present invention is to provide a newconvenient urinary incontinence treatment apparatus, the performance ofwhich may be affected by the patient at any time after operation, inparticular when various needs arise over the course of a day, so thatthe patient substantially always is satisfied or comfortable.

[0006] This object is achieved by a urinary incontinence treatmentapparatus of the kind stated initially characterised by an energytransmission device for wireless transmission of energy from outside thepatient's body to inside the patient's body for use in connection withthe operation of the restriction device including enlarging orrestricting the urine passageway, when the restriction device isimplanted.

[0007] As a result, the advantage is achieved that the urinaryincontinence treatment apparatus of the invention provides simple andeffective energy transmission that ensures long reliable function of theapparatus, possibly for the rest of the patient's life.

[0008] Generally, the apparatus comprises an energy transforming deviceimplantable in the patient for transforming the energy wirelesslytransmitted by the energy transmission device from a first form into asecond form, preferably different than the first form.

[0009] The energy transforming device may comprise at least onesemiconductor type of component or a circuitry of such semiconductorcomponents. The semiconductor component may comprise a transistor ormicrochip or similar electronic components. However, the semiconductorcomponent may not comprise rectifying diodes.

[0010] In accordance with a main embodiment of the invention, the energytransforming device comprises at least one element having a positiveregion and a negative region and adapted to create an energy fieldbetween the positive and negative regions when exposed to the energy ofthe first form transmitted by the energy transmission device, so thatthe energy field provides the energy of the second form. Typically, theabove-mentioned semiconductor component may include such an element.

[0011] In accordance with a preferred embodiment of the invention, theelement comprises an electrical junction element capable of inducing anelectric field between the positive and negative regions when exposed tothe energy of the first form transmitted by the energy transmissiondevice, whereby the energy of the second form comprises electric energy.

[0012] Consequently, the restriction device suitably is electricallyoperated, whereby the positive and negative regions of the electricaljunction element supply electric energy for the operation of therestriction device. The apparatus suitably comprises implantableelectric conductors connected to the positive and negative regions ofthe electrical junction element, whereby the electrical junction elementis capable of supplying an electric current, such as a direct current, apulsating direct current, a combination of a direct and pulsating directcurrent, an alternating current or a combination of a direct andalternating current, via the conductors. Furthermore, the electricaljunction element may be capable of supplying a frequency, amplitude, orfrequency and amplitude modulated analog, digital, or a combination ofanalog and digital signal, which is used in connection with control ofthe restriction device.

[0013] The element, preferably in the form of an electricalsemiconductor junction element, should be designed to generate an outputcurrent exceeding 1 μA when exposed to the energy of the first formtransmitted by the energy transmission device. Suitably the electricaljunction element forms a flat and thin sheet and has a volume of lessthan 2000 cm³ to be suited for subcutaneous implantation, so that theelectrical junction element can be located just behind the skin of thepatient. Alternatively, it would be possible to implant the element inthe thorax or cephalic region of the patient, or in an orifice of thepatient's body and under the mucosa or intraluminar outside the mucosaof the orifice. Of course, all the components of the energy transformingdevice including the electrical junction element in contact with thepatient's body should be of biocompatible material.

[0014] For in vitro appliances, a particular type of an electricalsemiconductor junction element has been commonly used, namely aso-called p-n (positive/negative) junction element, typically in theform of solar cells. A solar cell transfers solar energy in the form ofvisible light into electric energy in the form of direct current. Forexample, a p-n junction element may comprise two layers ofsemiconductor, one p-type (positive) and the other n-type (negative),sandwiched together to form a “p-n junction”. This p-n junction inducesan electric field across the element when absorbing quanta of light(photons).

[0015] To be more precise, the quanta of light transfer their energy tosome of the semiconductor's electrons, which are then able to move aboutthrough the material. For each such negatively charged electron, acorresponding positive charge—a “hole”—is created. In an ordinarysemiconductor, these electrons and holes recombine after a short timeand their energy is wasted as heat. However, when the electrons andholes are swept across the p-n junction in opposite directions by theaction of the electric field, the separation of charge induces a voltageacross the p-n junction element. By connecting the p-n junction elementto an external circuit, the electrons are able to flow thereby creatinga current.

[0016] Surprisingly, it has been proved that although both the skin andsubcutis absorb energy from an external light beam directed against theskin portion behind which a properly designed p-n junction element islocated, the light energy transmitted through the skin can induce acurrent from the p-n junction element strong enough (minimum 1 μA) toenable the operation of the electrically operated restriction device.Thus, such a p-n junction element is now for the first time used for invivo applications.

[0017] The apparatus may comprise an implantable pulse generator forgenerating electrical pulses from the energy of the second form producedby the energy field.

[0018] Generally, the energy transforming device is adapted to transformthe energy of the first form directly or indirectly into the energy ofthe second form.

[0019] In accordance with a preferred embodiment of the invention, theenergy of the second form comprises electric energy and the energytransforming device comprises a capacitor, which may be adapted toproduce electric pulses from the transformed electric energy.Preferably, the capacitor may be adapted to produce the pulses as theenergy transforming device transforms the energy of the first formtransmitted by the energy transmission device into the electric energyof the second form. The capacitor should be small to facilitateimplantation thereof; i.e. its capacity may not be more than 0,1 μF.

[0020] The apparatus may comprise an implantable stabiliser forstabilising the energy of the second form. Where the energy of thesecond form comprises electric current the stabiliser may comprise atleast one capacitor of the type described above.

[0021] In most embodiments of the invention, the apparatus comprisesimplantable electrical components. Where the electrical componentsinclude a capacitor of the type described above or an accumulator, atleast one, preferably a single, voltage level guard may advantageouslybe provided, wherein the charge and discharge of the capacitor oraccumulator is controlled by use of the voltage level guard. As aresult, there is no need for any implanted current detector and/orcharge level detector for the control of the capacitor, which makes theapparatus simple and reliable.

[0022] In a particular embodiment of the invention, the wireless energyof the first form comprises sound waves and the energy of the secondform comprises electric energy, wherein the energy transforming deviceis adapted to directly transform the sound waves into electric energy.

[0023] The apparatus may comprise an implantable motor or pump foroperating the restriction device, wherein the motor or pump is poweredby the transformed energy.

[0024] In accordance with a main aspect of the invention, the energytransmission device may be adapted to transmit wireless energy fordirect use in connection with the operation of the restriction device,as the wireless energy is being transmitted. The advantage of directlyusing energy as it is transmitted is that the apparatus can be of a verysimple design and the few components involved makes the apparatusextremely reliable. For example, the energy transmission device may beadapted to directly power the motor or pump with wireless energy. Thewireless energy may comprise a magnetic field or electromagnetic waves,suitably in the form of a signal, for direct power of the motor or pump.All the various functions of the motor and associated componentsdescribed in the present specification may be used where applicable.

[0025] As an alternative to the above-noted main aspect of theinvention, the energy transforming device may be adapted to supply theenergy of the second form for direct use in connection with theoperation of the restriction device, as the energy of the first form isbeing transformed into the energy of the second form. Consequently, theenergy transforming device may be adapted to directly power the motor orpump with the energy of the second form.

[0026] Generally, the energy transforming device directly operates therestriction device with the energy of the second form in a non-magnetic,non-thermal or non-mechanical manner.

[0027] Where the apparatus comprises a motor, which may be adapted todirectly or intermittently operate the restriction device, the energytransforming device may power the motor with the energy of the secondform. Suitably, the restriction device is operable to perform areversible function and the motor is capable of reversing said function.

[0028] In accordance with another embodiment of the invention, therestriction device comprises a hydraulic restriction device, and theapparatus comprises an implantable pump for operating the hydraulicrestriction device, wherein the energy transforming device supplies theenergy of the second form for driving the pump. Preferably, the pump isnot a plunger type of pump, but may comprise a peristaltic or membranepump.

[0029] The energy transforming device preferably is capable ofgenerating as the energy of the second form a current exceeding 1 μA,when transferring the energy of the first form transmitted by the energytransmission device.

[0030] The apparatus may comprise an implantable adjustment device foradjusting the restriction device to change the restriction of the urinepassageway. In accordance with a first alternative the adjustment deviceis adapted to mechanically adjust the restriction device. In accordancewith a second alternative the adjustment device is adapted tohydraulically adjust the restriction device by using implanted hydraulicmeans. Such hydraulic means may not use hydraulic fluid of the kindhaving a viscosity that substantially increases when exposed to heat ora magnetic field.

[0031] The apparatus of the present invention is not limited to the useof visible light for the wireless transmission of energy. Thus, inaccordance with a broad aspect of the invention, the energy transmissiondevice transmits energy by at least one wireless signal, preferablycontaining radiant energy.

[0032] The wireless signal may comprises a wave signal, for example anelectromagnetic wave signal, such as an infrared light signal, a visiblelight signal, an ultra violet light signal, a laser signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal, and a gammaradiation signal. Where applicable, one or more of the above signals maybe combined. Alternatively, the wave signal may comprise a sound wavesignal, such as an ultrasonic signal. Generally, the wireless signal maycomprise a digital, analog or a digital and analog signal.

[0033] The energy of the first form transmitted by the energytransmission device may comprise an electric or magnetic fieldtransmitted in pulses, for example digital pulses. Furthermore, theenergy transforming device may transform the energy of the first form,which may comprise polarised energy, into a direct current, pulsatingdirect current, a combination of a direct and pulsating direct current,an alternating current or a combination of a direct and alternatingcurrent. Alternatively, the energy of the first form may comprisekinetic energy.

[0034] The energy of the second form may comprise a frequency, amplitudeor frequency and amplitude modulated analog, digital or combined analogand digital signal.

[0035] The restriction device may be non-inflatable, i.e. with nohydraulic fluid involved for the adjustments of the restriction device.This eliminates problems with fluid leaking from the restriction device.

[0036] The apparatus suitably comprises implantable electric conductorsconnected to the energy transforming device, whereby the energytransforming device is capable of supplying an electric current, such asdirect current, a pulsating direct current, a combination of a directand pulsating direct current, an alternating current or a combination ofa direct and alternating current, via the conductors. Furthermore, theenergy transforming device may be capable of supplying a frequency,amplitude, or frequency and amplitude modulated analog, digital, or acombination of analog and digital signal, which is used in connectionwith control of the restriction device.

[0037] In accordance with a main embodiment of the invention, theapparatus comprises an implantable operation device for operating therestriction device and a control device for controlling the operationdevice, wherein the energy transforming device powers the operationdevice with the energy of the second form. The operation devicepreferably comprises a motor, for example an electric linear motor or anelectric rotary motor that is controlled by the control device to rotatea desired number of revolutions. Optionally, an implantable gearing maybe connected to the motor. The electric motor may have electricallyconductive parts made of plastics. Alternatively, the motor may comprisea hydraulic or pneumatic fluid motor, wherein the control devicecontrols the fluid flow through the fluid motor. Motors currentlyavailable on the market are getting smaller and smaller. Furthermore,there is a great variety of control methods and miniaturised controlequipment available. For example, the number of revolutions of a rotarymotor may be analysed by a Hall-element just a few mm in size.

[0038] In accordance with another embodiment of the invention, therestriction device comprises hydraulic means and the operation device isadapted to conduct a hydraulic fluid in the hydraulic means. Theoperation device comprises a fluid conduit connected to the hydraulicmeans of the restriction device, and a reservoir for fluid, wherein thereservoir forms part of the conduit. The reservoir may form a fluidchamber with a variable volume, and the operation device may be adaptedto distribute fluid from the chamber to the hydraulic means of therestriction device by reduction of the volume of the chamber and towithdraw fluid from the hydraulic means to the chamber by expansion ofthe volume of the chamber. The operation device suitably comprises animplantable motor used for reducing and expanding the volume of thechamber. Also, the operation device may comprise a pump for pumping thehydraulic fluid in the hydraulic means of the restriction device. All ofthe hydraulic components involved are preferably devoid of anynon-return valve. This is of great advantage, because with valvesinvolved there is always a risk of malfunction due to improperly workingvalves, especially when long time periods passes between valveoperations.

[0039] The control device may be adapted to reverse the operation deviceby shifting polarity of the energy of the second form. Where theoperation device comprises an electric motor the energy of the secondform suitably comprises electric energy.

[0040] In accordance with yet another embodiment of the invention, therestriction device is operable to perform a reversible function, such asenlarging and restricting the urine passageway, and there is a reversingdevice implanted in the patient for reversing the function performed bythe restriction device. Such a reversing function preferably involvesenlarging and restricting the urine passageway by the restrictiondevice, suitably in a stepless manner. In this connection, the controldevice suitably controls the reversing device, which may include aswitch, to reverse the function performed by the restriction device. Thereversing device may comprise hydraulic means including a valve forshifting the flow direction of a fluid in the hydraulic means.Alternatively, the reversing device may comprise a mechanical reversingdevice, such as a switch or a gearbox.

[0041] Where the reversing device comprises a switch it may be operableby the energy of the second form. In this case, the control devicesuitably controls the operation of the switch by shifting polarity ofthe energy of the second form supplied to the switch. The switch maycomprise an electric switch and the source of energy may supply electricenergy for the operation of the switch.

[0042] In accordance with an advantageous embodiment of the invention,the apparatus further comprises an energy storage device implanted inthe patient for storing the energy of the second form and for supplyingenergy in connection with the operation of the restriction device. Theimplanted energy storage device preferably comprises an electric sourceof energy, such as an accumulator, a rechargeable battery or acombination of an accumulator and rechargeable battery.

[0043] The apparatus may further comprise a switch implantable in thepatient for switching the operation of the restriction device and asource of energy implantable in the patient. This embodiment isparticularly suited for applications where the energy transmissionefficiency of the apparatus is insufficient, i.e. where the implantedrestriction device is to perform more advanced operations. Such a sourceof energy preferably is a battery. Alternatively, the source of energyis an accumulator that also may store the energy of the second form.

[0044] In accordance with a first alternative, the switch is operated bythe energy of the second form supplied by the energy storage device toswitch from an off mode, in which the source of energy is not in use, toan on mode, in which the source of energy supplies energy for theoperation of the restriction device. In this case, the implanted sourceof energy may comprise a battery, preferably having a lifetime of atleast 10 years, or an accumulator. However, other kinds of sources arealso conceivable, such as a nuclear source of energy or a chemicalsource of energy (fuel cells).

[0045] In accordance with a second alternative, the apparatus furthercomprises a remote control for controlling the supply of energy of theimplanted source of energy, wherein the switch is operated by the energyof the second form supplied by the energy storage device to switch froman off mode, in which the remote control is prevented from controllingthe source of energy and the source of energy is not in use, to astandby mode, in which the remote control is permitted to control thesource of energy to supply energy for the operation of the restrictiondevice.

[0046] In accordance with a third alternative, the energy storage deviceis omitted, wherein the switch is operated by the energy of the secondform supplied by the energy transforming device to switch from an offmode, in which the remote control is prevented from controlling thesource of energy and the source of energy is not in use, to a standbymode, in which the remote control is permitted to control the source ofenergy to supply energy for the operation of the restriction device.

[0047] In accordance with a fourth alternative, also the remote controlis omitted, wherein the switch is operated by the energy of the secondform supplied by the energy transforming device to switch from an offmode, in which the source of energy is not in use, to an on mode, inwhich the source of energy supplies energy for the operation of therestriction device. Where applicable, in the described embodiments theswitch may switch when the energy transmission device is transmittingwireless energy, preferably while the transferred energy of the secondform is stabilised by an implanted capacitor, which may temporarily (fora few seconds) store the energy of the second form.

[0048] In the above noted third and fourth alternatives, the energytransmission device may be substituted for the energy transformingdevice, whereby the switch is operated by the energy of the first form.

[0049] The switch mentioned above may comprise an electronic switch or,where applicable, a mechanical switch.

[0050] The advantage of using a switch above all is increased controlsafety; i.e. interfering signals in the patient's surroundings cannotaffect the implanted restriction device. Furthermore, the lifetime ofthe implanted source of energy will be significantly prolonged, sincethe energy consumption of the apparatus will be reduced to a minimum.During the above-mentioned standby mode, the remote control uses energyfrom the implanted source of energy. By means of the energy transmissiondevice energy may be transmitted to activate the switch to connect theimplanted source of energy only when energy is required in connectionwith the operation of the restriction device.

[0051] All of the above embodiments may be combined with at least oneimplantable sensor for sensing at least one physical parameter of thepatient, wherein the control device may control the restriction devicein response to signals from the sensor. For example, the sensor maycomprise a pressure sensor for directly or indirectly sensing thepressure against the restriction device, human tissue or in the urinepassageway, or the pressure against the urethra or the lower part of theurine bladder. The control device may comprise an internal control unitimplanted in the patient for, preferably directly, controlling therestriction device in response to signals from the sensor. In responseto signals from the sensor, for example pressure, the patient's positionor any other important physical parameter, the internal control unit maysend information thereon to outside the patient's body. The control unitmay also automatically control the restriction device in response tosignals from the sensor. For example, the control unit may control therestriction device to further restrict the urine passageway in responseto the sensor sensing that the patient is lying, or enlarge the urinepassageway in response to the sensor sensing an abnormally high pressureagainst the restriction device.

[0052] Alternatively, the control device may comprise an externalcontrol unit outside the patient's body for, suitably directly,controlling the restriction device in response to signals from thesensor. The external control unit may store information on the physicalparameter sensed by the sensor and may be manually operated to controlthe restriction device based on the stored information. In addition,there may be at least one implantable sender for sending information onthe physical parameter sensed by the sensor.

[0053] An external data communicator may be provided outside thepatient's body and an internal data communicator may be implanted in thepatient for communicating with the external communicator. The internalcommunicator may feed data related to the patient, or related to therestriction device, back to the external communicator. Alternatively orin combination, the external communicator may feed data to the internalcommunicator. The internal communicator may suitably feed data relatedto at least one physical signal of the patient.

[0054] The apparatus may further comprise an implantable programmablecontrol unit for controlling the restriction device, preferably overtime in accordance with an activity schedule program. This will advancethe apparatus and make possible an adaptation of the apparatus to theindividual patients.

[0055] Many of the above embodiments are suitably remote controlled.Thus, the apparatus advantageously comprises a wireless remote controltransmitting at least one wireless control signal for controlling therestriction device. With such a remote control it will be possible toadapt the function of the apparatus to the patient's need in a dailybasis, which is beneficial with respect to the treatment of the patient.The control signal may comprise a frequency, amplitude or frequency oramplitude modulated signal. Furthermore, the control signal may comprisean analog or a digital signal, or a combination of an analog and digitalsignal.

[0056] The wireless remote control may be capable of obtaininginformation on the condition of the implanted restriction device and ofcontrolling the restriction device in response to the information. Also,The remote control may be capable of sending information related to therestriction device from inside the patient's body to the outsidethereof.

[0057] In a particular embodiment of the invention, the wireless remotecontrol comprises at least one external signal transmitter ortransceiver and at least one internal signal receiver or transceiverimplantable in the patient. In another particular embodiment of theinvention, the wireless remote control comprises at least one externalsignal receiver or transceiver and at least one internal signaltransmitter or transceiver implantable in the patient.

[0058] The wireless remote control may transmit a carrier signal forcarrying the control signal, wherein the carrier signal is frequency,amplitude or frequency and amplitude modulated. The carrier signal mayalso comprise digital, analog or a combination of digital and analogsignals. Such signals may comprise wave signals. Also the control signalused with the carrier signal may be frequency, amplitude or frequencyand amplitude modulated, and be digital, analog or combined digital andanalog.

[0059] The control signal may comprise a wave signal, for example, asound wave signal, such as an ultrasound wave signal, an electromagneticwave signal, such as an infrared light signal, a visible light signal,an ultra violet light signal, a laser signal, a micro wave signal, aradio wave signal, an x-ray radiation signal, or a gamma radiationsignal. Where applicable, two or more of the above signals may becombined.

[0060] The control signal may be digital or analog, and may comprise anelectric or magnetic field. Suitably, the wireless remote control maytransmit an electromagnetic carrier wave signal for carrying the digitalor analog control signal. For example, use of an analog carrier wavesignal carrying a digital control signal would give safe communication.The control signal may be transmitted in pulses by the wireless remotecontrol.

[0061] The energy transmission device may function different from orsimilar to the energy transforming device. For example, the energytransmission and transforming devices function differently when theenergy transmission device comprises a coil used for transmitting theenergy of the first form and the energy transforming device comprises anelectrical junction element for transforming the transmitted energy intothe energy of the second form. The energy transmission and transformingdevices function similar to each other when the energy transmissiondevice comprises a coil used for transmitting the energy of the firstform and the energy transforming device also comprises a coil fortransforming the transmitted energy into the energy of the second form.

[0062] In accordance with an alternative embodiment of the invention,the apparatus comprises an activatable source of energy implantable inthe patient, wherein the source of energy is activated by wirelessenergy transmitted by the energy transmission device, to supply energywhich is used in connection with the operation of the restrictiondevice.

[0063] The implantable restriction device suitably is embedded in a softor gel-like material. For example, a silicone material having hardnessless than 20 Shore.

[0064] All the above described various components, such as the motor,pump and capacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable.

[0065] All the various ways of transferring, transforming andcontrolling energy presented in the present specification may bepractised by using all of the various components and solutionsdescribed.

[0066] The present invention also provides an implanting method,comprising the steps of providing a urinary incontinence treatmentapparatus described above, cutting an opening in a patient's mucosa inan orifice of the patient's body, and implanting the energy transformingdevice in the patient's body through the opening.

[0067] There is also provided a laparascopical implanting method, inaccordance with a first alternative, comprising the steps of providing aurinary incontinence treatment apparatus as described above, placing atleast two laparascopic cannula within a patient's body, and implantingthe energy transforming device in the patient's body by using the atleast two laparascopic cannula.

[0068] In accordance with a second alternative there is provided alaparoscopic surgical method of implanting a urinary incontinencetreatment apparatus, comprising the steps of laparascopically placing arestriction device of the apparatus through the abdomen or thorax of apatient, placing at least two laparoscopic trocars within the patient'sbody, using at least one dissecting tool inserted through thelaparoscopic trocar, introducing the restriction device through thetrocar, and placing the restriction device in engagement with theurethra or urine bladder to create a restricted urine passageway.

[0069] The method may further comprise implanting an energy transformingdevice of the apparatus, for example subcutaneously, in the abdomen,thorax or cephalic region, or other locations in the patient's body.

[0070] The method may further comprise postoperatively adjusting therestricted urine passageway in a non-invasive procedure.

[0071] The present invention also provides a method of treating a humanor animal having chronic urinary incontinence comprising:

[0072] (a) Surgically implanting in the human or animal a restrictiondevice engaging the human's or animal's urine bladder or urethra, toform a restricted passageway in the urethra or urine bladder.

[0073] (b) Surgically implanting in the human or animal an operationdevice, which can adjust the restricted passageway in response tosupplied energy. And, (c) in a non-invasive post-operative procedure,from time to time, supplying energy to the operation device so as toenlarge the restricted passageway to allow urine to readily passthrough. In the method (c) may be practised several times (e.g. 2-10) aday.

[0074] The invention is described in more detail in the following withreference to the accompanying drawings, in which

[0075] FIGS. 1 to 12 are schematic block diagrams illustrating twelveembodiments, respectively, of the urinary incontinence treatmentapparatus of the invention, in which wireless energy is transmitted fromoutside a patient's body to energy consuming components of the apparatusimplanted in the patient.

[0076]FIG. 13 is a schematic block diagram illustrating conceivablecombinations of implanted components for achieving various communicationoptions;

[0077]FIG. 14 illustrates an electrical junction element for use in theapparatus of the present invention; and

[0078]FIG. 15 illustrates the apparatus in accordance with the inventionimplanted in a patient;

[0079]FIG. 16 is a block diagram illustrating remote control componentsof an embodiment of the invention, in which wireless energy istransmitted by the use of electromagnetic signals; and

[0080]FIG. 17 is a schematic view of exemplary circuitry used for thecomponents of the block diagram of FIG. 16.

[0081] Referring to the drawing figures, like reference numeralsdesignate identical or corresponding elements throughout the severalfigures.

[0082]FIG. 1 schematically shows a most simple embodiment of the urineincontinence disease apparatus of the invention having some partsimplanted in a patient and other parts located outside the patient'sbody. Thus, in FIG. 1 all parts placed to the right of the patient'sskin 2 are implanted and all parts placed to the left of the skin 2 arelocated outside the patient's body.

[0083] The apparatus of FIG. 1 comprises an implanted operablerestriction device 4, which engages the patient's urethra (oralternatively engages the urine bladder) to form a restricted urinepassageway in the urethra. The restriction device 4 is capable ofperforming a reversible function, i.e. to enlarge and reduce thecross-sectional area of the urine passageway, whereby the restrictiondevice 4 works as an artificial sphincter. An implanted energytransforming device 6 is adapted to supply energy consuming componentsof the restriction device 4 with energy via a power supply line 12. Anexternal energy transmission device 10 includes a wireless remotecontrol for transmitting a wireless signal, which is received by asignal receiver incorporated in the implanted energy transforming device6. The implanted energy transforming device 6 transforms energy from thesignal into electric energy that is supplied via the power supply line12.

[0084]FIG. 2 shows an embodiment of the invention identical to that ofFIG. 1, except that a reversing device in the form of an electric switch14 energy also is implanted in the patient for reversing the restrictiondevice 4. The wireless remote control of the external energytransmission device 10 transmits a wireless signal that carries energyand the implanted energy transforming device 6 transforms the wirelessenergy into a current for operating the switch 14. When the polarity ofthe current is shifted by the energy transforming device 6 the switch 14reverses the function performed by the restriction device 4.

[0085]FIG. 3 shows an embodiment of the invention identical to that ofFIG. 1, except that an operation device in the form of a motor 15 foroperating the restriction device 4 also is implanted in the patient. Themotor 15 is powered with energy from the energy transforming device 6,as the remote control of the external energy transmission device 10transmits a wireless signal to the receiver of the energy transformingdevice 6.

[0086]FIG. 4 shows an embodiment of the invention identical to that ofFIG. 1, except that an assembly 16 including a motor/pump unit 18 and afluid reservoir 20 also is implanted in the patient. In this case therestriction device 4 is hydraulically operated, i.e. hydraulic fluid ispumped by the motor/pump unit 18 from the reservoir 20 through a conduit22 to the restriction device 4 to reduce the cross-sectional area of theurine passageway, and hydraulic fluid is pumped by the motor/pump unit18 back from the restriction device 4 to the reservoir 20 to enlarge thecross-sectional area. The implanted energy transforming device unit 6transforms wireless energy into a current, for example a current, forpowering the motor/pump unit 18 via an electric power supply line 24.

[0087]FIG. 5 shows an embodiment of the invention comprising theexternal energy transmission device 10 with its wireless remote control,the restriction device 4, in this case hydraulically operated, and theimplanted energy transforming device 6, and further comprising animplanted hydraulic fluid reservoir 30, an implanted motor/pump unit 32and an implanted reversing device in the form of a hydraulic valveshifting device 34. The motor of the motor/pump unit 32 is an electricmotor. In response to a control signal from the wireless remote controlof the external energy transmission device 10, the implanted energytransforming device 6 powers the motor/pump unit 32 with energy from theenergy carried by the control signal, whereby the motor/pump unit 32distributes hydraulic fluid between the reservoir 30 and the restrictiondevice 4. The remote control of the energy transmission device 10controls the shifting device 34 to shift the hydraulic fluid flowdirection between one direction in which the fluid is pumped by themotor/pump unit 32 from the reservoir 30 to the restriction device 4 toreduce the cross-sectional area of the urine passageway, and anotheropposite direction in which the fluid is pumped by the motor/pump unit32 back from the restriction device 4 to the reservoir 30 to enlarge thecross-sectional area.

[0088]FIG. 6 shows an embodiment of the invention identical to that ofFIG. 1, except that a control unit 36 controlled by the wireless remotecontrol of the external energy transmission device 10, an accumulator 38and a capacitor 40 also are implanted in the patient. The control unit36 stores electric energy received from the energy transforming device 6in the accumulator 38, which supplies energy to the restriction device4. In response to a control signal from the wireless remote control ofthe energy transmission device 10, the control unit 6 either releaseselectric energy from the accumulator 38 and transfers the releasedenergy via power lines 42 and 44, or directly transfers electric energyfrom the energy transforming device 6 via a power line 46, the capacitor40, which stabilises the electric current, a power line 48 and the powerline 44, for the operation of the restriction device 4.

[0089] In accordance with one alternative, the capacitor 40 in theembodiment of FIG. 6 may be omitted. In accordance with anotheralternative, the accumulator 38 in this embodiment may be omitted.

[0090]FIG. 7 shows an embodiment of the invention identical to that ofFIG. 1, except that a battery 50 for supplying energy for the operationof the restriction device 4 and an electric switch 52 for switching theoperation of the restriction device 4 also are implanted in the patient.The switch 52 is operated by the energy supplied by the energytransforming device 6 to switch from an off mode, in which the battery50 is not in use, to an on mode, in which the battery 50 supplies energyfor the operation of the restriction device 4.

[0091]FIG. 8 shows an embodiment of the invention identical to that ofFIG. 7, except that a control unit 36 controllable by the wirelessremote control of the external energy transmission device 10 also isimplanted in the patient. In this case, the switch 52 is operated by theenergy supplied by the energy transforming device 6 to switch from anoff mode, in which the wireless remote control is prevented fromcontrolling the control unit 36 and the battery is not in use, to astandby mode, in which the remote control is permitted to control thecontrol unit 36 to release electric energy from the battery 50 for theoperation of the restriction device 4.

[0092]FIG. 9 shows an embodiment of the invention identical to that ofFIG. 8, except that an accumulator 38 is substituted for the battery 50and the implanted components are interconnected differently. In thiscase, the accumulator 38 stores energy from the energy transformingdevice 6. In response to a control signal from the wireless remotecontrol of the external energy transmission device 10, the implantedcontrol unit 36 controls the switch 52 to switch from an off mode, inwhich the accumulator 38 is not in use, to an on mode, in which theaccumulator 38 supplies energy for the operation of the restrictiondevice 4.

[0093]FIG. 10 shows an embodiment of the invention identical to that ofFIG. 9, except that a battery 50 also is implanted in the patient andthe implanted components are interconnected differently. In response toa control signal from the wireless remote control of the external energytransmission device 10, the implanted control unit 36 controls theaccumulator 38 to deliver energy for operating the switch 52 to switchfrom an off mode, in which the battery 50 is not in use, to an on mode,in which the battery 50 supplies electric energy for the operation ofthe restriction device 4.

[0094] Alternatively, the switch 52 may be operated by energy suppliedby the accumulator 38 to switch from an off mode, in which the wirelessremote control is prevented from controlling the battery 50 to supplyelectric energy and is not in use, to a standby mode, in which thewireless remote control is permitted to control the battery 50 to supplyelectric energy for the operation of the restriction device 4.

[0095]FIG. 11 shows an embodiment of the invention identical to that ofFIG. 7, except that a motor 15, a mechanical reversing device in theform of a gearbox 54 and a control unit 36 for controlling the gearbox54 also are implanted in the patient. The implanted control unit 36controls the gearbox 54 to reverse the function performed by therestriction device 4 (mechanically operated).

[0096]FIG. 12 shows an embodiment of the invention identical to that ofFIG. 10 except that the implanted components are interconnecteddifferently. Thus, in this case the battery 50 powers the control unit36 when the accumulator 38, suitably a capacitor, activates the switch52 to switch to an on mode. When the switch 52 is in its on mode thecontrol unit 36 is permitted to control the battery 50 to supply, or notsupply, energy for the operation of the restriction device 4.

[0097]FIG. 13 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the implanted restriction device 4, control unit 36and motor/pump unit 18, and the external energy transmission device 10including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the implanted control unit 36, which in turn controls thevarious implanted components of the apparatus.

[0098] A sensor 56 may be implanted in the patient for sensing aphysical parameter of the patient, such as the pressure in the urinepassageway. The implanted control unit 36, or alternatively the externalwireless remote control of the energy transmission device 10, maycontrol the restriction device 4 in response to signals from the sensor56. A transceiver may be combined with the sensor 56 for sendinginformation on the sensed physical parameter to the external wirelessremote control. The wireless remote control may comprise a signaltransmitter or transceiver and the implanted control unit 36 maycomprise a signal receiver or transceiver. Alternatively, the wirelessremote control may comprise a signal receiver or transceiver and theimplanted control unit 36 may comprise a signal transmitter ortransceiver. The above transceivers, transmitters and receivers may beused for sending information or data related to the restriction device 4from inside the patient's body to the outside thereof.

[0099] Where the motor/pump unit 18 and battery 50 for powering themotor/pump unit 18 are implanted, the battery 50 may be equipped with atransceiver for sending information on the condition of the battery 50.

[0100] Those skilled in the art will realise that the above variousembodiments according to FIGS. 1-13 could be combined in many differentways. For example, the energy operated switch 14 could be incorporatedin any of the embodiments of FIGS. 3, 6-12, the hydraulic shiftingdevice 34 could be incorporated in the embodiment of FIG. 4, and thegearbox 54 could be incorporated in the embodiment of FIG. 3.

[0101]FIG. 14 shows an energy transforming device in the form of anelectrical junction element 58 for use in any of the above embodimentsaccording to FIGS. 1-13. The element 58 is a flat p-n junction elementcomprising a p-type semiconductor layer 60 and an n-type semiconductorlayer 62 sandwiched together. A light bulb 64 is electrically connectedto opposite sides of the element 58 to illustrate how the generatedcurrent is obtained. The output of current from such a p-n junctionelement 58 is correlated to the temperature. See the formula below.

I=I 0 (exp.(qV/kT)−1)

[0102] where

[0103] I is the external current flow,

[0104] I0 is the reverse saturation current,

[0105] q is the fundamental electronic charge of 1.602×10-19 coulombs,

[0106] V is the applied voltage,

[0107] k is the Boltzmann constant, and

[0108] T is the absolute temperature.

[0109] Under large negative applied voltage (reverse bias), theexponential term becomes negligible compared to 1.0, and I isapproximately −I0. I0 is strongly dependent on the temperature of thejunction and hence on the intrinsic-carrier concentration. I0 is largerfor materials with smaller bandgaps than for those with larger bandgaps.The rectifier action of the diode—that is, its restriction of currentflow to only one direction—is in this particular embodiment the key tothe operation of the p-n junction element 58.

[0110] An alternative way to design a p-n junction element is to deposita thin layer of semiconductor onto a supporting material which does notabsorb the kind of energy utilised in the respective embodiments. Foruse with wirelessly transmitted energy in terms of light waves, glasscould be a suitable material. Various materials may be used in thesemiconductor layers such as but not limited to cadmium telluride,copper-indium-diselenide and silicon. It is also possible to use amultilayer structure with several layers of p and n-type materials toimprove efficiency.

[0111] The electric energy generated by the p-n junction element 58could be of the same type as generated by solar cells, in which thenegative and positive fields create a direct current. Alternatively, thenegative and positive semiconductor layers may change polarity followingthe transmitted waves, thereby generating an alternating current.

[0112] The p-n junction element 58 is designed to make it suited forimplantation. Thus, all the external surfaces of the element 58 incontact with the human body are made of a biocompatible material. Thep-n junction semiconductors are designed to operate optimally at a bodytemperature of 37° C. because the current output, which should be morethan 1 μA, is significantly depending on temperature as shown above.Since both the skin and subcutis absorb energy, the relation between thesensitivity or working area of the element 58 and the intensity orstrength of the wireless energy transmission is considered. The p-njunction element 58 preferably is designed flat and small.Alternatively, if the element 58 is made in larger sizes it should beflexible, in order to adapt to the patient's body movements. The volumeof the element 58 should be kept less than 2000 cm³.

[0113]FIG. 15 generally illustrates how any of the above-describedembodiments of the urine incontinence disease treatment apparatus of theinvention may be implanted in a patient. Thus, a restriction device 4implanted in a patient engages the urethra 66 to form an artificialsphincter around the urine passageway in the urethra 66. An implantedoperation device 68, such as an electric motor or a motor/pump assembly,operates the restriction device 4 through a transmission member 70, suchas a mechanical transmission cord or a fluid tube. An energytransforming device in the form of an element 6 having a positive regionand a negative region, as described above in more detail, is placedunderneath the skin of the patient.

[0114] Wireless energy carried by a signal transmitted by a wirelessremote control of an external energy transmission device 10 at leastpartly penetrates the patient's skin and hits the element 6. The energythus hitting the element 6 is transformed into energy of a differentform that is suited for powering the operation device 68. For example,where the operation device 68 is an electric motor the element 6comprises an electric p-n junction element that transforms the wirelessenergy into an electric current for powering the electric motor. Wherethe operation device 68 comprises a pump, the element 6 may transformthe wireless energy into kinetic energy for powering the pump.

[0115] The transformed energy may be utilised for directly operating therestriction device 4 or, where the restriction device 4 is electricallyoperated, for storage in a capacitor and/or an accumulator for later orparallel use. Preferably (but not necessarily) the element 6 iscontrolled by a microprocessor. The wireless remote control of theexternal energy transmission device 10 is used to control theutilisation of the transmitted energy and any function or commandto/from the implanted restriction device 4.

[0116]FIG. 16 shows the basic parts of a wireless remote control of theapparatus of the invention including an electric motor 128 for operatinga restriction member, for example of the type illustrated in FIG. 15. Inthis case, the remote control is based on the transmission ofelectromagnetic wave signals, often of high frequencies in the order of100 kHz-1 gHz, through the skin 130 of the patient. In FIG. 15, allparts placed to the left of the skin 130 are located outside thepatient's body and all parts placed to the right of the skin 130 areimplanted. Any suitable remote control system may be used.

[0117] An external signal transmitting antenna 132 is to be positionedclose to a signal receiving antenna 134 implanted close to the skin 130.As an alternative, the receiving antenna 134 may be placed for exampleinside the abdomen of the patient. The receiving antenna 134 comprises acoil, approximately 1-100 mm, preferably 25 mm in diameter, wound with avery thin wire and tuned with a capacitor to a specific high frequency.A small coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

[0118] An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas132,134 to an implanted control unit 138. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 is connected to the microprocessor thereof. The keypad is usedto order the microprocessor to send digital signals to either contractor enlarge the restriction device. The microprocessor starts a commandby applying a high frequency signal on the antenna 132. After a shorttime, when the signal has energised the implanted parts of the controlsystem, commands are sent to contract or enlarge the restriction devicein predefined steps. The commands are sent as digital packets in theform illustrated below. Start pattern, Command, Count, Checksum, 8 bits8 bits 8 bits 8 bits

[0119] The commands are sent continuously during a rather long timeperiod (e.g. about 30 seconds or more). When a new contract or enlargestep is desired the Count byte is increased by one to allow theimplanted control unit 138 to decode and understand that another step isdemanded by the external control unit 136. If any part of the digitalpacket is erroneous, its content is simply ignored.

[0120] Through a line 140, an implanted energiser unit 126 draws energyfrom the high frequency electromagnetic wave signals received by thereceiving antenna 134. The energiser unit 126 stores the energy in anenergy storage device, such as a large capacitor, powers the controlunit 138 and powers the electric motor 128 via a line 142.

[0121] The control unit 138 comprises a demodulator and amicroprocessor. The demodulator demodulates digital signals sent fromthe external control unit 136. The microprocessor of the control unit138 receives the digital packet, decodes it and, provided that the powersupply of the energiser unit 126 has sufficient energy stored, sends asignal via a signal line 144 to the motor 128 to either contract orenlarge the restriction device depending on the received command code.

[0122] Alternatively, the energy stored in the energy storage device ofthe energiser unit may only be used for powering a switch, and theenergy for powering the motor 128 may be obtained from another implantedenergy source of relatively high capacity, for example a battery. Inthis case the switch is adapted to connect said battery to the controlunit 138 in an on mode when said switch is powered by the energy storagedevice and to keep the battery disconnected from the control unit in astandby mode when the switch is not powered.

[0123] With reference to FIG. 17, the remote control schematicallydescribed above will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of theapparatus. The power amplifier 150 amplifies the signals and sends themto the external signal transmitting antenna 132. The antenna 132 isconnected in parallel with a capacitor 152 to form a resonant circuittuned to the frequency generated by the signal generator 148.

[0124] The implanted signal receiving antenna coil 134 forms togetherwith a capacitor 154 a resonant circuit that is tuned to the samefrequency as the transmitting antenna 132. The signal receiving antennacoil 134 induces a current from the received high frequencyelectromagnetic waves and a rectifying diode 160 rectifies the inducedcurrent, which charges a storage capacitor 158. A coil 156 connectedbetween the antenna coil 134 and the diode 160 prevents the capacitor158 and the diode 160 from loading the circuit of the signal receivingantenna 134 at higher frequencies. Thus, the coil 156 makes it possibleto charge the capacitor 158 and to transmit digital information usingamplitude modulation.

[0125] A capacitor 162 and a resistor 164 connected in parallel and adiode 166 forms a detector used to detect amplitude modulated digitalinformation. A filter circuit is formed by a resistor 168 connected inseries with a resistor 170 connected in series with a capacitor 172connected in series with the resistor 168 via ground, and a capacitor174, one terminal of which is connected between the resistors 168,170and the other terminal of which is connected between the diode 166 andthe circuit formed by the capacitor 162 and resistor 164. The filtercircuit is used to filter out undesired low and high frequencies. Thedetected and filtered signals are fed to an implanted microprocessor 176that decodes the digital information and controls the motor 128 via anH-bridge 178 comprising transistors 180,182,184 and 186. The motor 128can be driven in two opposite directions by the H-bridge 178.

[0126] The microprocessor 176 also monitors the amount of stored energyin the storage capacitor 158. Before sending signals to activate themotor 128, the microprocessor 176 checks whether the energy stored inthe storage capacitor 158 is enough. If the stored energy is not enoughto perform the requested operation, the microprocessor 176 waits for thereceived signals to charge the storage capacitor 158 before activatingthe motor 128.

1. A urinary incontinence treatment apparatus, comprising a restrictiondevice implantable in a patient, who suffers from urinary incontinence,for engaging the urethra or urine bladder, to form a restricted urinepassageway in the urethra or urine bladder, the restriction device beingoperable to change the restriction of the urine passageway,characterised by an energy transmission device for wireless transmissionof energy from outside the patient's body to inside the patient's bodyfor use in connection with the operation of the restriction deviceincluding enlarging or restricting the urine passageway, when therestriction device is implanted.
 2. An apparatus according to claim 1,wherein the energy transmission device transmits energy of a first formand the restriction device is operable in response to energy of a secondform, and further comprising an energy transforming device implantablein the patient for transforming the energy of the first form wirelesslytransmitted by the energy transmission device into the energy of thesecond form.
 3. An apparatus according to claim 2, wherein the energy ofthe second form is different than the energy of the first form.
 4. Anapparatus according to claim 2 or 3, wherein the energy transformingdevice comprises at least one element having a positive region and anegative region, the element is capable of creating an energy fieldbetween the positive and negative regions when exposed to the energy ofthe first form transmitted by the energy transmission device, and theenergy field produces the energy of the second form.
 5. An apparatusaccording to claim 4, wherein the element comprises an electricaljunction element, and the electrical junction element is capable ofinducing an electric field between the positive and negative regionswhen exposed to the energy of the first form transmitted by the energytransmission device, whereby the energy of the second form compriseselectric energy.
 6. An apparatus according to claim 5, wherein therestriction device is electrically operated, and the positive andnegative regions of the electrical junction element supply electricenergy for the operation of the restriction device.
 7. An apparatusaccording to claim 6, further comprising electric conductors connectedto the positive and negative regions of the electrical junction element,whereby the electrical junction element is capable of supplying anelectric current via the conductors.
 8. An apparatus according to claim7, wherein the electrical junction element is capable of supplying adirect current or pulsating direct current via the conductors.
 9. Anapparatus according to claim 7, wherein the electrical junction elementis capable of supplying an alternating current or a combination of adirect and alternating current via the conductors.
 10. An apparatusaccording to claim 6, wherein the electrical junction element is capableof supplying a frequency or amplitude modulated signal.
 11. An apparatusaccording to claim 6, wherein the electrical junction element is capableof supplying an analog or digital signal.
 12. An apparatus according toany of claims 2-11, wherein the energy transforming device forms a flatand thin sheet, and has a volume of less than 2000 cm³.
 13. An apparatusaccording to claim 2 or 3, wherein the energy transforming device isadapted to transform the energy of the first form directly or indirectlyinto the energy of the second form.
 14. An apparatus according to claim13, further comprising an implantable motor or pump for operating therestriction device, wherein the motor or pump is powered by the energyof the second form.
 15. An apparatus according to claim 14, wherein theenergy transforming device is adapted to directly power the motor orpump by the transformed energy, as the energy of the second form isbeing transformed from the energy of the first form.
 16. An apparatusaccording to any of claims 13-15, wherein the wireless energy of thefirst form comprises sound waves and the energy of the second formcomprises electric energy.
 17. An apparatus according to any of claims2-16, wherein the energy transforming device comprises a capacitor andthe energy of the second form comprises electric energy.
 18. Anapparatus according to claim 17, wherein the capacitor is adapted toproduce electric pulses from the transformed electric energy.
 19. Anapparatus according to claim 18, wherein the capacitor is adapted toproduce the pulses of the electric energy, as the energy transformingdevice transforms the energy of the first form transmitted by the energytransmission device into the electric energy of the second form.
 20. Anapparatus according to claim 2, further comprising an implantablestabiliser for stabilising the energy of the second form.
 21. Anapparatus according to claim 20, wherein the energy of the second formcomprises electric current and the stabiliser comprises at least onecapacitor.
 22. An apparatus according to any of the preceding claims,further comprising implantable electrical components including at leastone voltage level guard.
 23. An apparatus according to any of claims1-21, further comprising implantable electrical components including asingle voltage level guard.
 24. An apparatus according to claim 22 or23, wherein the electrical components are devoid of any current detectorand/or charge level detector.
 25. An apparatus according to any ofclaims 22-24, further comprising an implantable capacitor oraccumulator, wherein the charge or discharge of the capacitor oraccumulator is controlled by use of the voltage level guard.
 26. Anapparatus according to any of claims 17-19,21 and 25, wherein thecapacitor has a capacity less than 0,1 μF.
 27. An apparatus according toclaim 1, wherein the energy transmission device is adapted to transmitwireless energy for direct use in connection with the operation of therestriction device, as the wireless energy is being transmitted.
 28. Anapparatus according to claim 27, further comprising an implantable motoror pump for operating the restriction device, wherein the energytransmission device is adapted to directly power the motor or pump withwireless energy.
 29. An apparatus according to claim 28, wherein theenergy transmission device is adapted to transmit wireless energy in theform of a magnetic field or electromagnetic waves for direct power ofthe motor or pump
 30. An apparatus according to claim 2, wherein theenergy transforming device is adapted to supply the energy of the secondform for direct use in connection with the operation of the restrictiondevice, as the energy of the first form is being transformed into theenergy of the second form.
 31. An apparatus according to claim 30,further comprising an implantable motor or pump for operating therestriction device, wherein the energy transforming device is adapted todirectly power the motor or pump with the energy of the second form. 32.An apparatus according to claim 31, wherein the energy transformingdevice directly operates the restriction device with the energy of thesecond form in a non-magnetic, non-thermal or non-mechanical manner. 33.An apparatus according to any of claims 2-12, further comprising animplantable motor for direct or intermittent operation of therestriction device, wherein the energy transforming device powers themotor with the energy of the second form.
 34. An apparatus according toclaim 33, wherein the restriction device is operable to perform areversible function and the motor is capable of reversing said function.35. An apparatus according to any of claims 2-27 and 30, wherein therestriction device comprises a hydraulic restriction device, and furthercomprising an implantable pump for operating the hydraulic restrictiondevice, the energy transforming device supplying the energy of thesecond form for driving the pump.
 36. An apparatus according to any ofclaims 28, 29, 31 and 35, wherein the pump is not a plunger type ofpump.
 37. An apparatus according to any of the preceding claims, whereinthe energy transforming device is capable of generating as the energy ofthe second form a current exceeding 1 μA, when transferring the energyof the first form transmitted by the energy transmission device.
 38. Anapparatus according to any of the preceding claims, further comprisingan adjustment device for adjusting the restriction device to change therestriction of the urine passageway, wherein the adjustment device isadapted to mechanically adjust the restriction device, or adapted tohydraulically adjust the restriction device by using hydraulic meanswhich is devoid of hydraulic fluid of the kind having a viscosity thatsubstantially increases when exposed to heat or a magnetic field.
 39. Anapparatus according to any of claims 2-12, wherein the energytransforming device comprises at least one semiconductor type ofcomponent.
 40. An apparatus according to claim 39, wherein the energytransforming device comprises a circuitry of semiconductor components.41. An apparatus according to claim 39, wherein the semiconductorcomponent comprises a transistor or microchip or similar electroniccomponents excluding rectifying diodes.
 42. An apparatus according toclaim 40 or 41, wherein the semiconductor component comprises at leastone element having a positive region and a negative region, the elementis capable of creating an energy field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy transmission device, and the energy field produces the energy ofthe second form.
 43. An apparatus according to any of the precedingclaims, further comprising an implantable operation device for operatingthe restriction device, wherein the energy transforming device powersthe operation device with the energy of the second form.
 44. Anapparatus according to claim 43, further comprising a control device forcontrolling the operation device.
 45. An apparatus according to claim 43or 44, wherein the operation device comprises a motor.
 46. An apparatusaccording to claim 33 or 45, further comprising an implantable gearingconnected to the motor.
 47. An apparatus according to claims 44 and 45,wherein the motor comprises a rotary motor and the control devicecontrols the rotary motor to rotate a desired number of revolutions. 48.An apparatus according to claim 45, wherein the motor comprises a linearmotor.
 49. An apparatus according to claim 44 and 45, wherein the motorcomprises a hydraulic or pneumatic fluid motor, and the control devicecontrols the fluid motor.
 50. An apparatus according to claim 45,wherein the motor comprises an electric motor having electricallyconductive parts made of plastics.
 51. An apparatus according to claim43, wherein the restriction device comprises hydraulic means and theoperation device is adapted to conduct a hydraulic fluid in thehydraulic means.
 52. An apparatus according to claim 51, wherein theoperation device comprises a fluid conduit connected to the hydraulicmeans of the restriction device, and a reservoir for fluid, thereservoir forming part of the conduit.
 53. An apparatus according toclaim 52, wherein the hydraulic means and conduit are devoid of anynon-return valve.
 54. An apparatus according to claim 53, wherein thereservoir forms a fluid chamber with a variable volume, and theoperation device is adapted to distribute fluid from the chamber to thehydraulic means of the restriction device by reduction of the volume ofthe chamber and to withdraw fluid from the hydraulic means to thechamber by expansion of the volume of the chamber.
 55. An apparatusaccording to claim 54, wherein the operation device comprises animplantable motor used for reducing and expanding the volume of thechamber.
 56. An apparatus according to any of claims 51-53, wherein theoperation device comprises an implantable pump for pumping the hydraulicfluid in the hydraulic means of the restriction device.
 57. An apparatusaccording to claim 44, wherein the control device shifts polarity of theenergy of the second form to reverse the operation device.
 58. Anapparatus according to claim 45 or 57, wherein the operation devicecomprises an electric motor and the energy of the second form compriseselectric energy.
 59. An apparatus according to any of claims 1, 43 and44, wherein the restriction device is operable to perform a reversiblefunction.
 60. An apparatus according to claim 59, further comprising areversing device implantable in the patient for reversing the functionperformed by the restriction device.
 61. An apparatus according toclaims 44 and 60, wherein the control device controls the reversingdevice to reverse the function performed by the restriction device. 62.An apparatus according to claim 60 or 61, wherein the reversing devicecomprises hydraulic means including a valve for shifting the flowdirection of a fluid flow in the hydraulic means.
 63. An apparatusaccording to claim 60 or 61, wherein the reversing device comprises amechanical reversing device.
 64. An apparatus according to claim 63,wherein the reversing device comprises a gearbox.
 65. An apparatusaccording to claim 60 or 61, wherein the reversing device comprises aswitch.
 66. An apparatus according to claim 65, wherein the switch isoperable by the energy of the second form.
 67. An apparatus according toclaim 66, wherein the control device controls the operation of theswitch by shifting polarity of the energy of the second form.
 68. Anapparatus according to claim 66 or 67, wherein the switch comprises anelectric switch and the energy of the second form comprises electricenergy.
 69. An apparatus according to claim 43, wherein the operationdevice comprises hydraulic means and at least one valve for controllinga fluid flow in the hydraulic means.
 70. An apparatus according to claim69, further comprising a wireless remote control for controlling thevalve.
 71. An apparatus according to any one of claims 18, 19 and 44,wherein the control device is adapted to control the energy transformingdevice to produce the energy of the second form in a train of energypulses for direct use in connection with the operation of therestriction device.
 72. An apparatus according to claim 2, furthercomprising an energy storage device implantable in the patient forstoring the energy of the second form and for supplying energy inconnection with the operation of the restriction device.
 73. Anapparatus according to claim 72, wherein the energy storage devicecomprises an accumulator.
 74. An apparatus according to claim 73,wherein the energy of the second form comprises electric energy and theenergy storage device comprises an electric accumulator.
 75. Anapparatus according to claim 74, wherein the electric accumulatorcomprises at least one capacitor or at least one rechargeable battery,or a combination of at least one capacitor and at least one rechargeablebattery.
 76. An apparatus according to any of claims 2, 65, 71-75,further comprising a switch implantable in the patient for directly orindirectly switching the operation of the restriction device.
 77. Anapparatus according to claim 76, further comprising a source of energyimplantable in the patient, wherein the switch is operated by the energyof the second form supplied by the energy storage device to switch froman off mode, in which the source of energy is not in use, to an on mode,in which the source of energy supplies energy for the operation of therestriction device.
 78. An apparatus according to claim 76, furthercomprising a source of energy implantable in the patient, and a remotecontrol for controlling the supply of energy of the source of energy,wherein the switch is operated by the energy of the second form suppliedby the energy storage device to switch from an off mode, in which theremote control is prevented from controlling the source of energy andthe source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.
 79. An apparatusaccording to claim 76, further comprising a source of energy implantablein the patient for supplying energy for the operation of the restrictiondevice, wherein the switch is operated by the energy of the second formsupplied by the energy transforming device to switch from an off mode,in which the source of energy is not in use, to an on mode, in which thesource of energy supplies energy for the operation of the restrictiondevice.
 80. An apparatus according to claim 76, further comprising asource of energy implantable in the patient for supplying energy for theoperation of the restriction device, and a remote control forcontrolling the supply of energy of the implantable source of energy,wherein the switch is operated by the energy of the second form suppliedby the energy transforming device to switch from an off mode, in whichthe remote control is prevented from controlling the source of energyand the source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.
 81. An apparatusaccording to claim 76, further comprising a source of energy implantablein the patient for supplying energy for the operation of the restrictiondevice, wherein the switch is operated by the energy of the first formsupplied by the energy transmission device to switch from an off mode,in which the source of energy is not in use, to an on mode, in which thesource of energy supplies energy for the operation of the restrictiondevice.
 82. An apparatus according to claim 76, further comprising asource of energy implantable in the patient for supplying energy for theoperation of the restriction device, and a remote control forcontrolling the supply of energy of the implantable source of energy,wherein the switch is operated by the energy of the first form suppliedby the energy transmission device to switch from an off mode, in whichthe remote control is prevented from controlling the source of energyand the source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.
 83. An apparatusaccording to claim 2, wherein the restriction device is electricallyoperated, and the energy of the second form comprises electric energy.84. An apparatus according to claim 83, further comprising electricconductors connected to the energy transforming device, whereby theenergy transforming device is capable of supplying an electric currentvia the conductors.
 85. An apparatus according to claim 2, wherein theenergy transforming device is capable of supplying a frequency,amplitude or frequency and amplitude modulated signal.
 86. An apparatusaccording to claim 2, wherein the energy transforming device is capableof supplying an analog, digital or a combination of an analog anddigital signal.
 87. An apparatus according to claim 1, furthercomprising an activatable source of energy implantable in the patient,wherein the source of energy is activated by wireless energy transmittedby the energy transmission device, to supply energy which is used inconnection with the operation of the restriction device.
 88. Anapparatus according to claim 1, wherein the energy transmission devicetransmits energy by at least one wireless signal.
 89. An apparatusaccording to claim 88, wherein the signal contains radiant energy. 90.An apparatus according to claim 88, wherein the signal comprises a wavesignal.
 91. An apparatus according to claim 90, wherein the wave signalcomprises an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a micro wave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal.
 92. An apparatusaccording to claim 90, wherein the wave signal comprises a sound orultrasound wave signal.
 93. An apparatus according to any one of claims88-92, wherein the signal comprises a digital or analog signal, or acombination of a digital and analog signal.
 94. An apparatus accordingto claim 2, wherein the energy of the first form transmitted by theenergy transmission device comprises an electric, an electromagnetic ora magnetic field, or a combination thereof.
 95. An apparatus accordingto claim 94, wherein the electric, electromagnetic or magnetic field, orthe combination thereof is transmitted in pulses or digital pulses, or acombination of pulses and digital pulses by the energy transmissiondevice.
 96. An apparatus according to claim 2, wherein the energy of afirst form transmitted by the energy transmission device comprises anelectric, an electromagnetic or a magnetic field, or a combinationthereof.
 97. An apparatus according to claim 96, wherein the electric,electromagnetic or magnetic field, or the combination thereof istransmitted in waves or analog pulses or a combination thereof by theenergy transmission device.
 98. An apparatus according to any one ofclaims 1-97, wherein the energy transmitted by the energy transmissiondevice comprises polarised energy.
 99. An apparatus according to claim2, wherein the energy transforming device transforms the energy of thefirst form into a direct current or pulsating direct current, or acombination of a direct current and pulsating direct current.
 100. Anapparatus according to claim 2, wherein the energy transforming devicetransforms the energy of the first form into an alternating current or acombination of a direct and alternating current.
 101. An apparatusaccording to claim 2, further comprising an implantable pulse generatorfor generating electrical pulses from the energy of the second formproduced by the energy field.
 102. An apparatus according to any one ofthe preceding claims, further comprising at least one implantable sensorfor sensing at least one physical parameter of the patient.
 103. Anapparatus according to claim 102, wherein the sensor comprises apressure sensor for directly or indirectly sensing as the physicalparameter the pressure in the urine passageway or the pressure againstthe urethra or the lower part of the urine bladder.
 104. An apparatusaccording to claim 102, further comprising a control device forcontrolling the restriction device in response to signals from thesensor.
 105. An apparatus according to claim 104, wherein the controldevice comprises an internal control unit implantable in the patient forcontrolling the restriction device in response to signals from thesensor.
 106. An apparatus according to claim 105, wherein the internalcontrol unit directly controls the restriction device in response tosignals from the sensor.
 107. An apparatus according to claim 104,wherein the control device comprises an external control unit outsidethe patient's body for controlling the restriction device in response tosignals from the sensor.
 108. An apparatus according to claim 107,wherein the external control unit stores information on the physicalparameter sensed by the sensor and is manually operated to control therestriction device based on the stored information.
 109. An apparatusaccording to any one of claims 102-108, further comprising at least oneimplantable sender for sending information on the physical parametersensed by the sensor.
 110. An apparatus according to any one of thepreceding claims, further comprising a wireless remote control fortransmitting at least one wireless control signal for controlling therestriction device.
 111. An apparatus according to claim 110, whereinthe control signal comprises a frequency, amplitude or frequency oramplitude modulated signal.
 112. An apparatus according to claim 110,wherein the control signal comprises an analog or a digital signal, or acombination of an analog and digital signal.
 113. An apparatus accordingto any of claims 110-112, wherein the remote control is capable ofobtaining information on the condition of the implantable restrictiondevice and to control the restriction device in response to theinformation.
 114. An apparatus according to any of claims 110-113,wherein the remote control comprises an implantable control unit forcontrolling the restriction device.
 115. An apparatus according to claim114, wherein the control unit comprises a microprocessor.
 116. Anapparatus according to any one of claims 110-115, wherein the wirelessremote control comprises at least one external signal transmitter ortransceiver and at least one internal signal receiver or transceiverimplantable in the patient.
 117. An apparatus according to any one ofclaims 110-115, wherein the wireless remote control comprises at leastone external signal receiver or transceiver and at least one internalsignal transmitter or transceiver implantable in the patient.
 118. Anapparatus according to any one of claims 110-117, wherein the remotecontrol is capable of sending information related to the restrictiondevice from inside the patients body to the outside thereof.
 119. Anapparatus according to claim 118, wherein the remote control controlsthe restriction device in response to the information.
 120. An apparatusaccording to any one of claims 110-119, wherein the remote controlcomprises a control signal transmitter for transmitting the wirelesscontrol signal, and the energy transmission device comprises the controlsignal transmitter, whereby energy is transmitted by the control signal.121. An apparatus according to any one of claims 110-119, wherein theenergy transmission device transmits energy by at least one signalseparate from the control signal.
 122. An apparatus according to any oneof claims 110-119, wherein the remote control transmits a carrier signalfor carrying the control signal.
 123. An apparatus according to any oneof claims 110-119, wherein the energy transmission device transmitsenergy by at least one signal, which is used as a carrier signal for thecontrol signal transmitted by the remote control.
 124. An apparatusaccording to claim 123, wherein the carrier signal is frequency,amplitude or frequency and amplitude modulated.
 125. An apparatusaccording to claim 123 or 124, wherein the carrier signal comprisesdigital, analog or a combination of digital and analog signals.
 126. Anapparatus according to claim 125, wherein the signals comprise wavesignals.
 127. An apparatus according to any one of claims 110-126,wherein the control signal comprises a wave signal comprising one of asound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a micro wave signal, a radiowave signal, an x-ray radiation signal and a gamma radiation signal.128. An apparatus according to any one of claims 110-126, wherein thecontrol signal comprises an electric or magnetic field, or a combinedelectric and magnetic field.
 129. An apparatus according to claim 112,wherein the remote control transmits an electromagnetic carrier wavesignal for carrying the digital or analog control signal.
 130. Anapparatus according to claim 2, wherein the energy of the second formused for operating the restriction device is wirelessly transmitted bythe energy transforming device.
 131. An apparatus according to claim 1,further comprising an implantable control unit for controlling therestriction device.
 132. An apparatus according to claim 131, whereinthe control unit is programmable for controlling the restriction devicein accordance with a program.
 133. An apparatus according to claim 131,wherein the control unit controls the restriction device over time inaccordance with an activity schedule program
 134. An apparatus accordingto any one of claims 131-133, further comprising an external wirelessremote control for programming the implantable control unit.
 135. Anapparatus according to claim 1, further comprising an external datacommunicator and an implantable internal data communicator communicatingwith the external data communicator, wherein the internal communicatorfeeds data related to the restriction device back to the external datacommunicator or the external data communicator feeds data to theinternal data communicator.
 136. An apparatus according to claim 135,wherein the internal data communicator feeds data related to at leastone physical signal of the patient.
 137. An apparatus according to anyone of the preceding claims, wherein the restriction device is adaptedto control the restriction of the urine passageway when implanted. 138.An apparatus according to any one of the preceding claims, wherein therestriction device is non-inflatable.
 139. An apparatus according toclaim 2, wherein one of the energy of the first form and the energy ofthe second form comprises magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy.
 140. An apparatus according to claim2, wherein one of the energy of the first form and the energy of thesecond form is non-magnetic, non-kinetic, non-chemical, non-sonic,non-nuclear or non-thermal.
 141. An apparatus according to claim 1,wherein the energy transmission device functions different from theenergy transforming device.
 142. An apparatus according to claim 2,wherein the energy transmission device functions similar to the energytransforming device.
 143. An apparatus according to any one of thepreceding claims, wherein the energy transforming device is designed tobe implanted subcutaneously or in the abdomen, thorax or cephalic regionof the patient.
 144. An apparatus according to any one of claims 1-142,wherein the energy transforming device is designed to be implanted in anorifice of the patient's body and under the mucosa or intraluminaroutside the mucosa of the orifice.
 145. An apparatus according to any ofthe preceding claims, wherein the restriction device is embedded in asoft or gel-like material.
 146. An apparatus according to any of thepreceding claims, wherein the restriction device is embedded in asilicone material having hardness less than 20 Shore.